Surgical implant

ABSTRACT

A surgical implant has a mesh-like base structure ( 2 ) and a film ( 4 ). The film ( 4 ) extends over at least part of the base structure ( 2 ), is connected to the base structure ( 2 ) in partial regions, and has a coefficient of kinetic friction, relative to rat skin, of not more than 0.25. The film ( 4 ) is preferably absorbable.

The invention relates to a surgical implant which, for example, can beused to repair inguinal hernias.

EP 0 898 944 A2 discloses a hernia implant in which a two-layer base ispositioned in the preperitoneal space beneath the hernial orifice bymeans of a deployment device. A channel issuing from the base extendsthrough the hernial orifice and is provided with a collar at its end. Adisadvantage here is that the base does not always reliably deployinside the preperitoneal space and its edge may become folded or getstuck. Moreover, the base remains relatively rigid.

US 20030078602 A1 discloses a two-layer hernia implant in which onelayer is absorbable and the other layer is not absorbable.

DE 196 13 730 A1 describes an areal implant for strengthening or closureof body tissue, in which implant an absorbable film can be applied as atemporary stiffening material to one or both sides of a mesh-like basestructure.

DE 101 55 842 A1 discloses an areal implant with a mesh-like basestructure which is stable over a long period of time, has poresmeasuring in the range of 1.5 mm to 8 mm and is provided, at least in apartial region, with a synthetic and absorbable polymer film on bothsides. The two polymer films are bonded or welded to one another in thepores of the base structure.

Areal implants comprising a film permit only poor growth of tissuethrough them, because the applied film constitutes a barrier. If thefilm is absorbable, this disadvantageous effect is present at leasttemporarily.

WO 2004/012627 A1 discloses a hernia implant with a retention structurewhich constitutes an aid for deployment and stabilizing of the implant.This implant comprises two stiff, superposed meshes, with small pores,made of polypropylene, a sewn-on membrane made of e-PTFE, and areinforcement ring made of polyethylene terephthalate in a sewn channelinside the polypropylene mesh pouch.

A disadvantage of this is that the polypropylene mesh pouch represents alarge amount of material, is stiff and adapts only poorly to theanatomical circumstances, which leads to an excessive foreign-bodyreaction with formation of a scar plate. Moreover, the microporousmembrane made of e-PTFE is not incorporated in the tissue but instead isenclosed by a tissue capsule; adhesion is avoided.

U.S. Pat. No. 6,224,616 B1 discloses a hernia implant with two mesh-likelayers between which a pouch is formed. The pouch contains a springstructure which opens the implant out in one plane. The edge of thisimplant may fold up or over during use, which is a disadvantage.

A further hernia implant is known from U.S. Pat. No. 6,669,735 B1. Here,an absorbable ring is secured on the periphery of a non-absorbable mesh,which ring is bendable but resumes its original shape after deformation.

U.S. Pat. No. 5,368,602 A discloses a flexible surgical mesh with atleast one elongate, semi-rigid element which constitutes an aid forinsertion of the implant. The semi-rigid elements can be formedintegrally with the mesh or as separate components.

There are, in principle, disadvantages in deploying an implant mesh inthe preperitoneal space by means of an absorbable or non-absorbablespreader ring or similar application aids (for example nitinol wires orspring wires).

Thus, it is reported that the ring can break, entailing the risk ofperforation of the intestine. When, in the course of normal woundhealing, the tissue grows into the mesh, a scar forms and leads to woundcontraction. The mesh into which the tissue has grown is thereby alsocontracted, but the spreader ring does not take part in thiscontraction. This can cause a three-dimensional deformation of the mesh,and the deformed mesh can then no longer perform the function of closingthe hernia.

It is an object of the invention to make available a surgical implantwhich is suitable in particular for hernia repair, can easily deploy inthe intraperitoneal space, for example, permits good growth of tissuethrough it during the entire healing process and does not later lead tocomplications.

This object is achieved by a surgical implant having the features ofclaim 1. Advantageous embodiments of the invention are set out in thedependent claims.

The surgical implant according to the invention has a mesh-like basestructure and a film which extends over at least part of the basestructure. The film is connected to the base structure in partialregions of the film. The film is preferably absorbable. The coefficientof kinetic friction between film and rat skin is not more than 0.25.This figure relates to dry (i.e. not pre-moistened) film. A testprocedure for determining the coefficients of kinetic friction and alsothe corresponding coefficients of static friction is explained in detailfurther below.

The coefficient of kinetic friction between film and rat skin can bewithin any range whose lower limit is greater than 0 and smaller thanthe upper limit, and whose upper limit is not more than 0.25; allpossible numerical values for this are herewith considered as havingbeen disclosed.

When the implant according to the invention or parts thereof which havethe abovementioned features are introduced into the preperitoneal space,the disadvantages outlined above in relation to the previously knownimplants do not occur. The implant is fitted in such a way that, afterplacement in the preperitoneal space, the side with the mesh-like basestructure points towards the transversalis fascia (i.e. outwards) andthe film side points towards the peritoneum (i.e. the intestinal side).By virtue of the film, the implant provides sufficient initial stiffnessfor reliable deployment in the preperitoneal space, but, in the case ofan absorbable film, the implant parts in the preperitoneal space aresufficiently soft after a few days or within a few weeks, and goodincorporation of body tissue is also permitted. Moreover, deployment isfacilitated by the relatively low friction between the film and the bodytissue. After absorption of the film, an areal implant structure withgood tissue incorporation and of greatly reduced stiffness is leftwithin the preperitoneal space.

Reliable deployment or spreading-out is also ensured without a spreaderring or similar, that is to say the edge configuration of the implantdoes not endanger the patient. The film, at least on part of the edge ofthe base structure, preferably reaches at least as far as the edge ofthe base structure and optionally even extends beyond the edge of thebase structure. In this way, an edge is obtained which is easilypalpable and has an atraumatic configuration. It is of advantage if thefilm extends beyond the edge of the base structure, because then, duringapplication, the mesh webs at the ends do not catch so easily in thebody tissue. If the film is connected to the base structure at least onpart of the edge of the base structure (and preferably about the entirecircumference of the base structure), the edge of the base structurecannot fold or bend over. These features make handling the implant mucheasier.

According to the invention, the film is not connected to the mesh-likebase structure across the entire surface, but only in partial regions,e.g. at points and/or in the edge area.

Therefore, the mesh side can be reliably incorporated into the fasciastructures, since sufficient hollow spaces are present between film andmesh-like base structure, and the base structure can adapt well to thecontour of the body tissue lying over it. Within the first hours anddays of wound-healing, fibrin is admitted, not just on one side, but soas to enclose the mesh webs, with the result that, in this early phaseof wound-healing, the base structure and the implant are held in astable position by means of processes taking place in the body. In thisway, it is also possible to achieve fixation of the implant, for exampleby means of rapidly absorbable suture material, as a result of whichdisadvantages can be avoided, for example in inguinal hernia repair.This is because implants in inguinal hernia repair are usually fixedwith non-absorbable suture material, for example polypropylene, which inisolated cases can lead to chronic pain and to irritation of the nerves.

As has already been mentioned, the film ensures reliable deployment ofthe implant. The properties of the film in this respect can be adjusted,for example via its material, stiffness or thickness or the nature ofthe preliminary treatment (e.g. stretching). In preferred embodiments,the film has a thickness in the range of 0.01 mm to 3 mm, preferably inthe range of 0.025 mm to 1 mm, and its bending modulus of elasticity isless than 2500 N/mm². Special configuration of the edge is not needed,because the film has sufficient stiffness.

The film greatly reduces the friction relative to the underlying bodytissue, while the mesh-like base structure has a higher coefficient ofkinetic friction or of static friction relative to the tissue and bearsclosely on the overlying tissue. A test procedure for determiningcoefficients of friction of mesh structures and films relative to animaltissue is described further below. The results show that the friction ofmeshes is typically at least twice as high as the friction of selectedfilms relative to body tissue.

In preferred embodiments, the difference in the coefficients of kineticfriction of the film in the dry state and in the wet state is less than0.2, preferably less than 0.1. This distinguishes the film from, forexample, collagen-coated materials which, in the moist state, haveconsiderably lower coefficients of friction than in the dry state, aswill be explained further below in the example.

The film can be connected to the base structure in different ways, e.g.sewn on, embroidered, or bonded on (including by thermal means) inpartial regions (e.g. in points or along lines or strips, such as theperipheral edge) or welded thermally. The welding techniques here alsoinclude, in the wider sense, thermal deformation of the film (below themelting point of the film). A connection between film and base structureis conceivable in the edge area, for example, but also in areal patternsor, for example, as an arrow shape. The data for the coefficients offriction relate to the film as such, without friction-increasingeffects, e.g. embroidered patterns.

The preferred connection techniques are embroidering or sewing, sincethe implants are predominantly sterilized by ethylene oxidesterilization. The reason is that, in the case of adhesively bondedpoints or melted-on points, it is not possible to reliably avoidpossible microorganisms becoming trapped in these adhesion points ormelt points, in the production process, and thus not being killed off bythe sterile gas.

Examples of embroidered patterns or sewn patterns are given furtherbelow. An embroidered edge can also be configured so that it ispalpable, which can facilitate handling of the implant. The implant canalso have embroidered structures designed as reinforcements, e.g.rib-like structures.

The implant according to the invention can be formed as an arealstructure, e.g. by consisting only of a mesh-like structure with film.However, the implant can also be formed as a three-dimensionalstructure, e.g. by having a mesh-like base structure with film and alsoadditional structures which are of three-dimensional configuration. Anexpansion into the third dimension can also be achieved with aninherently areal structure (that is to say, for example, a mesh-likebase structure with film) which is curved and, if appropriate,stabilized in its shape.

In an advantageous embodiment, the implant has two wings extendingacross one another and spaced apart from one another, at least one ofsaid wings having a mesh-like base structure and a film with thefeatures discussed above. The two wings can in this case be connected bya cylinder-like structure designed for insertion into a hernial orifice.Such implants are suitable for treatment of hernias, in particular ifthe implant is intended to cover a hernial gap in the preperitonealspace. The wing configure according to the invention in this case comesto lie in the preperitoneal space, as has been explained above, and theother wing is fitted above this one, into the body tissue. Implants ofcomparable geometry are sold by Ethicon under the name “PHS” (ProleneHernia System), see also EP 0 898 944 B1. Other geometries forthree-dimensional implants according to the invention are alsoconceivable.

The film can be provided with one or more perforations, for example, inthe “PHS” geometry, with a central opening (e.g. 18 mm diameter), inorder to permit better placement in the preperitoneal space.

Examples for the material of the mesh-like base structure are polymersof alpha-olefins (including fluorine-containing alpha-olefins), e.g.polypropylene, polyvinylidene fluoride, aliphatic polyesters (e.g. ofglycolic acid or lactic acid), aromatic polyesters (e.g. polyethyleneterephthalate), and also copolymers or mixtures thereof. Particularlysuitable examples are mixtures of polyvinylidene fluoride and copolymersof vinylidene fluoride and hexafluoropropylene, sold by Ethicon underthe name “Pronova”. Partially absorbable mesh structures are alsoadvantageous; suitable examples of these are structures with “Vicryl”(Polyglactin 910, copolymer of glycolide and lactide in the ratio 90:10,Ethicon) and polypropylene, structures with “Monocryl” (Polyglecaprone25, copolymer of glycolide and s-caprolactone, Ethicon) and “Pronova” orpreferably structures with “Monocryl” and polypropylene. Aliphaticpolyesters or polyether esters are especially suitable for theabsorbable component.

The base structure can have a multifilament mesh, a monofilament mesh,or also a mesh configured as a mix of monofilaments and multifilaments.The elasticity behaviour of the base structure can be adapted in themanner described in DE 196 13 730 A1. Meshes with small pores or mesheswith monofilament reinforcements are likewise conceivable.

The mesh-like base structure can also be coated, for examplemetal-coated (with titanium or zirconium or other metals). Coatings arealso suitable which receive active substances (drug carriers) that arereleased after implantation. Examples of additives are internalplasticizers (e.g. citrates), or active substances such as triclosan,which can be incorporated into the base structure, for example by themethod described in DE 103 55 189 A1.

The film preferably contains polymers and/or copolymers of lactides,glycolides, caprolactone, trimethylene carbonate, polyhydroxybutyrateand/or polyhydroxy-valerate. Other advantageous materials arepoly-p-dioxanone (PDS) and polyoxaester. As a constituent of the implantaccording to the invention, the film also has coefficients of frictionwithin the required range. In a given film, the coefficient of frictionalso depends, inter alia, on the method of production of the film, whichalso determines the surface properties. The question of whether a givenfilm has a coefficient of friction within the required range, and istherefore suitable for the implant according to the invention, can beeasily ascertained by a skilled person carrying out specific tests.

Complete or partial colouring of the implant facilitates its orientationduring the operation.

As has been explained, the surgical implant according to the inventionis especially suitable for hernia repair, particularly if the implant isintended to cover a hernial gap in the preperitoneal space.

However, if the film is additionally equipped with anti-adhesion means(e.g. coated with ORC or collagen) or if it is made of polyoxaester oris coated with polyoxaester, this implant can also be fitted in theintraperitoneal space.

The invention is described in more detail below with reference toexamples. In the drawings:

FIG. 1 shows a diagrammatic longitudinal section through a region of animplant according to the invention, with a mesh-like base structure anda film,

FIG. 2 shows a diagrammatic plan view of an embodiment of the implantaccording to the invention, and

FIG. 3 shows, in parts (a) to (f), various embodiments of a wing,configured according to the invention, of a two-winged hernial implant,in diagrammatic plan views.

EXAMPLES OF GEOMETRIC SHAPES

FIG. 1 shows a diagrammatic longitudinal section through a region of asurgical implant 1. The implant 1 has a mesh-like base structure 2, e.g.crochet galloon, and a film 4 which, in the illustrative embodiment, isabsorbable. The film 4 is connected to the base structure 2 by a seam 6in partial regions of the base structure 2; the longitudinal sectionaccording to FIG. 1 extends through such a partial region. In theillustrative embodiment, the seam 6 is a double saddle stitch seam.

FIG. 2 shows a diagrammatic plan view of an embodiment of the implant,designated by 10. The dark lines 12 (zones) are the partial regions inwhich the film is connected to the base structure, e.g. by seams orembroidering. A partial region of this kind runs along the periphery ofthe base structure and extends as far as the edge 16 of the basestructure. The film is therefore securely connected to the basestructure in the edge area of the base structure. The film itself canalso extend beyond the edge 16, but this is not shown in FIG. 2.

In FIG. 3, six embodiments for a lower wing 20 (base) of a two-wingedhernia implant are shown in parts (a) to (f) in diagrammatic plan views.A hernia implant of this kind has a further wing (collar) which runs ata distance from the base 20 and is connected to the base 20 via acylindrical structure. The underlying geometrical principle (“PHS”geometry) of such a hernia implant is described in EP 0 898 944 A2. Thebase 20 is configured according to the invention. For simplicity, thesame reference numbers are used in parts (a) to (f) of FIG. 3.

The base 20 is constructed similarly to the implant 10 according to FIG.1 and has a base structure and a film which is connected to the basestructure in the dark, linear zones 22, e.g. by sewing, embroidering,gluing or welding. The circular area 24 marks the site of application ofthe aforementioned cylindrical structure. In the illustrativeembodiments, one of the zones 22 runs along the edge 26 of the basestructure, but the film can also extend beyond the edge 26.

As can be seen from parts (a) to (f) in FIG. 3, the zones 22 can alsoserve to reinforce the structure, e.g. in the form of radially extendingor circular reinforcements.

Other Examples of Embodiments

Table 1 below shows summarized examples of embodiments and materialcombinations, specifically for two-winged surgical implants with the“PHS” geometry for treatment of hernias (see above). In these implants,the wing (underlay) configured according to the invention is fitted inthe preperitoneal space and the other wing (overlay) is fitted abovethis; both wings are linked by a connector which comes to lie in thehernial orifice.

The material designations here, and in the rest of the text, are asfollows:

-   PP: Polypropylene (sold by Ethicon under the name “Prolene”)-   Vicryl: Polyglactin 910, copolymer of glycolide and lactide in the    ratio 90:10 (Ethicon)-   Monocryl: Polyglecaprone 25, copolymer of glycolide and    ε-caprolactone (Ethicon)-   Pronova: Mixture of polyvinylidene fluoride and copolymer of    vinylidene fluoride and hexafluoropropylene (Ethicon)-   PDS: Poly-p-dioxanone    “Vicryl”, “Monocryl” and “Pronova” are trade names of Ethicon.

TABLE 1 Underlay Overlay with Embroidered connector Mesh Film Shape edgeEmbroidery yarn PP PP/Monocryl Monocryl Round Only at edge AbsorbablePP/Vicryl PP/Vicryl Polydioxanone Oval Several at Non-absorbable uniformspacing PP/Monocryl Pronova Thickness: Ellipse Monofilament 50 μmPronova Pronova/ Thickness: With central Multifilament MonocrylPreferably 200 μm perforation Pronova/ Thicknesses: 50 Coloured orMonocryl to 500 μm uncoloured

The bending modulus of elasticity of films can be measured in athree-point bending test (e.g. distance of the bearings 20 mm, crossheadspeed 25 mm/min). For “Monocryl” films of different thicknesses, thisgives ca. 450 N/mm².

In the illustrative embodiments, the films used in the implants orimplant parts configured according to the invention are absorbable.“Monocryl” has a breaking-strength loss (measured after incubation in aphosphate buffer at 37° C.) of less than 10% of the original breakingstrength within ca. 3 to 20 days. A likewise suitable film of PDS has acorresponding breaking-strength loss after ca. 10 to 50 days.

Examples of Bonding

The film can be connected to the mesh-like structure with the aid of asecond film by means of thermal bonding. It must be ensured that thebonding of the two films to one another and to the mesh takes placeunder sterile conditions.

In one example of this, a “Monocryl” film was bonded to an “Ultrapro”mesh (base structure; “Ultrapro”: implant mesh sold by Ethicon withpolypropylene and “Monocryl”), specifically by means of an intermediatelayer (second film) arranged in partial regions of the “Monocryl” filmand made of a thin “PDS” film. In the example, the “PDS” film was meltedon at 130° C. in order to serve as an adhesive film between the“Monocryl” film (melting point ca. 190° C.) and the “Ultrapro” mesh(melting point ca. 165° C.).

Determination of the Coefficients of Friction

The coefficients of friction (coefficient of kinetic friction andcoefficient of static friction) of the film were measured relative torat skin, using a rat model, since the results are easy to reproduce,and rat tissue is easily obtainable.

For this purpose, a test specimen with the film to be examined is placedflat on a metal plate. Freshly prepared rat skin is placed, free fromfolds, on a square cork board (slide) so that the superficial fascia ispointing outwards. The square cork board with the rat skin (contactsurface between test specimen and the superficial fascia of the rat ca.10×10 cm) is loaded with a defined weight (pressing force) and pulledover the test specimen at a test speed of 200 mm/min with a tensiontesting machine (flexible wire, one end secured on the cork board, thesecond end on the load cell of the tension testing machine, the wireguided round low-friction rollers). The static friction and kineticfriction forces are determined from the resulting force-distancediagram, and from this it is possible to calculate a coefficient ofstatic friction and a coefficient of kinetic friction (as quotient ofthe frictional force and pressing force exerted by the tension testingmachine).

In the tests carried out, the selected pressing force and the contactsurface resulted in a contact pressure of ca. 730 Pa (5.5 mmHg), whichcorresponds to low intra-abdominal pressures. (In the tension-freestate, the intra-abdominal pressure is between 200 Pa (1.5 mmHg) and 800Pa (6 mmHg; U. Klinge et al.: Pathophysiologie der Bauchdecken[Pathophysiology of the abdominal wall], Der Chirurg (1196) 67:229-233). A doubling of the contact pressure to ca. 1730 Pa (13 mmHg)led directly proportionally to a doubling of the frictional forces,while the coefficients of friction in the examined pressure range (up toabout 2200 Pa or 16.5 mmHg) remained almost unchanged, that is to sayare to be seen as “matter constants”.

Results of Friction Measurements

According to measurements carried out using the model explained above(rat model), the kinetic friction force of commercially available meshesis in the order of 5N, whereas a “Monocryl” film, for example, haskinetic friction forces of less than 1 N.

In contrast to collagen film, for example, the frictional force of“Monocryl” film is not appreciably influenced by surrounding fluids. Thecomparison values for collagen film are ca. 3.5 N (dry) and ca. 0.5 N(wet), measured on the collagen film side of the “Parietex” mesh implantfrom Sofradim; in coatings with “Interceed” (oxidized regeneratedcellulose), there are similar differences between the dry and the wetstate.

Meshes or implants fitted in the dry state and coated on one side withcollagen film, or meshes fitted in the dry state and coated with“Interceed”, have the disadvantage that they deploy poorly in thepreperitoneal space and are difficult to position since, on the onehand, the mesh webs get caught and, on the other hand, the much highercoefficient of friction makes deployment on the peritoneal layerdifficult.

Table 2 shows the measurement results in detail for different samplescompared to commercially available standard implants. The samplesdesignated by 1 and 2 are the films of implants according to theinvention, while the other samples are conventional implants.

The coefficients of static friction and of kinetic friction of films ofthe implant according to the invention are ca. 0.03 to ca. 0.20 for thedry state and the wet state and are much lower in comparison toconventional implant meshes. The differences between the measurements inthe wet state and in the dry state are less than 0.1. By contrast,collagen film for example (as constituent of the “Parietex” mesh implantfrom Sofradim, a spacer knit with collagen film; sample 3) showscoefficients of friction of ca. 0.6 (static friction) and 0.34 (kineticfriction) in the dry state, while, in the wet state, the collagen filmhas a coefficient of friction of ca. 0.06 to 0.07. Implants which arenot moistened and are coated on one side with collagen film deploy onlypoorly in the preperitoneal space. These differences between wet and dryare even more pronounced, for example, in implants which are coated withORC (oxidized regenerated cellulose; trade name, e.g. “Interceed”;sample 4), for example the “Proceed” implant (sample 5), or whichcontain ORC. The coefficients of kinetic friction and of static frictionin the dry state are greater than 1 and decrease markedly in the wetstate, depending on the amount of water taken up.

The coefficients of friction of commercially available implants ofpolypropylene (“Prolene”; sample 6) are lower in the dry state andhigher in the moist state and are of the order of above 0.25 to ca. 0.7for static friction and above 0.15 to ca. 0.5 for kinetic friction. Amesh with large pores such as “Vypro II” (Ethicon; sample 7), comprisinga polypropylene component and an aliphatic polyester (“Vicryl”), tendsto have higher coefficients of friction than a pure polypropylene mesh.The “Vypro” mesh (Ethicon; sample 8) also contains polypropylene and“Vicryl”. Another large-pore mesh with an absorbable component(“Monocryl”) and a non-absorbable component of polypropylene is the“Ultrapro” mesh (Ethicon; sample 9).

TABLE 2 Frictional force Coefficient of Force [N] friction Measurementstate applied Static Kinetic Static Kinetic Sample Material wet dry [N]friction friction friction friction 1 “Monocryl” x 7.62 0.39 0.34 0.050.04 film x 7.62 0.29 0.24 0.04 0.03 x 7.62 0.52 0.40 0.07 0.05 x 7.620.33 0.24 0.04 0.03 2 PDS film 100 μm x 7.62 0.43 0.41 0.06 0.05 250 μmx 7.62 1.43 0.45 0.19 0.06 250 μm x 7.62 0.10 0.50 0.10 0.07 3“Parietex” Knit x 7.67 7.05 6.80 0.92 0.89 mesh side x 7.67 7.88 7.701.03 1.00 Film x 7.67 4.56 2.60 0.59 0.34 side x 7.67 0.52 0.45 0.070.06 4 “Interceed” Front x 7.62 12.00 12.00 1.57 1.57 x 7.62 10.09 9.501.32 1.25 5 “Proceed” “Interceed” x 7.62 9.60 9.00 1.26 1.18 side x 7.6218.86 12.00 2.48 1.57 6 “Prolene” Front x 7.49 2.82 1.40 0.38 0.19 meshx 7.49 1.99 1.15 0.27 0.15 (5 mil = x 7.49 5.08 4.60 0.68 0.61 0.127 mmx 7.49 4.67 4.20 0.62 0.56 “Prolene” Back x 7.49 2.52 2.00 0.34 0.27lengthwise) x 7.49 2.99 2.60 0.40 0.35 x 7.49 2.79 2.35 0.37 0.31 x 7.493.20 2.60 0.43 0.35 x 7.49 2.69 2.10 0.36 0.28 “Prolene” Front x 7.492.18 2.50 0.29 0.33 mesh x 7.49 2.85 2.20 0.38 0.29 (5 mil = x 7.49 3.502.00 0.47 0.27 0.127 mm Back x 7.49 3.06 1.90 0.41 0.25 “Prolene” x 7.493.14 1.85 0.42 0.25 crosswise) x 7.49 4.20 3.60 0.56 0.48 x 7.49 4.703.65 0.63 0.49 7 “Vypro II” Lengthwise x 7.21 6.59 5.80 0.91 0.80 x 7.215.95 5.80 0.83 0.80 x 7.21 5.87 5.60 0.81 0.78 x 7.21 6.14 5.60 0.850.78 x 7.21 4.26 4.10 0.59 0.57 x 7.21 4.48 4.10 0.62 0.57 x 7.21 4.244.10 0.59 0.57 x 7.21 4.50 4.10 0.62 0.57 8 “Vypro” Lengthwise x 14.428.89 8.00 0.62 0.55 x 21.63 14.84 14.00 0.69 0.65 9 “Ultrapro” x 7.215.24 5.10 0.73 0.71 x 7.21 5.33 5.10 0.74 0.71 x 7.21 5.43 5.00 0.750.69

1. Surgical implant comprised of a mesh-like base structure and a film,which film extends over at least part of the base structure, isconnected to the base structure in partial regions, and has acoefficient of kinetic friction, relative to rat skin, of not more than0.25.
 2. Implant according to claim 1, characterized in that the film isabsorbable.
 3. Implant according to claim 1, characterized in that thefilm, at least on part of an edge of the base structure, reaches atleast as far as the edge of the base structure and optionally extendsbeyond the edge of the base structure.
 4. Implant according to claim 1,characterized in that the film is connected to the base structure atleast on part of an edge of the base structure.
 5. Implant according toclaim 1, characterized in that the film is connected to the basestructure in at least one of the following ways comprised of: sewn on,embroidered, glued on in partial regions, or welded on in partialregions.
 6. Implant according to claim 1, characterized in that theimplant has embroidered structures designed as reinforcements. 7.Implant according to claim 1, characterized in that the film has athickness in the range of 0.01 mm to 3 mm.
 8. Implant according to claim1, characterized in that the film has a bending modulus of elasticity ofless than 2500 N/mm².
 9. Implant according to claim 1, characterized inthat the difference in the coefficients of kinetic friction of the filmin the dry state and in the wet state is less than 0.2.
 10. Implantaccording to claim 1, characterized in that the implant is formed as anareal structure.
 11. Implant according to claim 1, characterized in thatthe implant is formed as a three-dimensional structure.
 12. Implantaccording to claim 1, characterized in that the implant has two wingsextending across one another and spaced apart from one another, at leastone of said wings having a mesh-like base structure and a film with thefeatures according to claim
 1. 13. Implant according to claim 12,characterized in that the two wings are connected by a cylinder-likestructure designed for insertion into a hernial orifice.
 14. Implantaccording to claim 1, characterized in that the base structure iscomprised of at least one of the materials mentioned in the followinglist: polypropylene, polyvinylidene-fluoride, polymers of alpha-olefins,polymers of fluorine-containing alpha-olefins, mixturesof-21-polyvinylidene fluoride and copolymers of vinylidene fluoride andhexafluoropropylene, aliphatic polyesters. aliphatic polyesters ofglycolic acid, aliphatic polyesters of lactic acid, copolymers ofglycolide and lactide, copolymers of glycolide and 8-caprolactone,aromatic polyesters, polyethylene terephthalate, or polyether ester. 15.Implant according to claim 1, characterized in that the film iscomprised of at least one of the materials mentioned in the followinglist: polymers and copolymers of lactides, glycolides, caprolactone,trimethylene carbonate, polyhydroxybutyrate, polyhydroxyvalerate,poly-p-dioxanone, or polyoxaester.
 16. Implant according to claim 1,characterized in that the base structure is comprised of at least one ofthe elements mentioned in the following list: monofilaments,multifilaments, coatings, coatings with metal, coatings with titanium,coatings with zirconium, coatings configured as medicament supports,internal plasticizers, citrates as internal plasticizers, activesubstances, or triclosan as active substance.
 17. Implant according toclaim 1, characterized in that the film has at least one perforation.